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FDA 510(k)

Austin Miller Large External Fixation System

K-Number: K181528 · 2019-02-28

ApplicantAustin Miller Trauma, LLC
Decision Date2019-02-28
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Austin Miller Large External Fixation System is a medical device manufactured by Austin Miller Trauma, LLC. It received FDA 510(k) clearance on 2019-02-28 under approval number K181528. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Austin Miller Large External Fixation System?

Austin Miller Large External Fixation System is a medical device that received FDA 510(k) clearance on 2019-02-28. It is manufactured by Austin Miller Trauma, LLC. The 510(k) number is K181528.

When was Austin Miller Large External Fixation System approved by the FDA?

Austin Miller Large External Fixation System received FDA 510(k) clearance on 2019-02-28, under approval number K181528.

What company makes Austin Miller Large External Fixation System?

Austin Miller Large External Fixation System is manufactured by Austin Miller Trauma, LLC.

What is the FDA product code for Austin Miller Large External Fixation System?

The FDA product code for Austin Miller Large External Fixation System is KTT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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